SchizophreniaAMAISNCT00144027
Patient-Centered Medication Adherence Intervention for Schizophrenia
A study testing Antipsychotic medication adherence intervention in people with Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Antipsychotic medication adherence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical chart diagnosis of schizophrenia or schizoaffective disorder;
- currently prescribed outpatient antipsychotic medication (oral or depot);
- patient must have adequate capacity to provide informed consent, understand the nature of the study, and sign an informed consent document.
Who cannot join
- significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation-Memory-Concentration (BOMC) Test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
About this study
Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. One reason for this is the substantial resource investment necessary to implement and sustain available interventions. In response to these problems, we developed a patient-centered adherence intervention based on patient-identified barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention includes a BFM survey (checklist and preference weighting exercise to determine the patient's most important BFM) and a brief list of adherence enhancing suggestions (Options List) tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention. The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to: 1. Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction, provider intervention input, and patient intervention input. We hypothesize that our use of end-user input will result in at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2. Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity. We hypothesize that the intervention will result in a) greater medication adherence and b) lower schizophrenia symptom severity than usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life. We hypothesize that the intervention will result in greater health-related quality of life than usual care.
Read the detailed description
BFM intervention refinement will be accomplished in five phases. Phase one will include reducing the number of items in the BFM checklist by administering the expanded checklist to at least 50 patients with schizophrenia and using the standard psychometric item-reduction strategies to create a shorter checklist. In phase two we will conduct mental health provider focus groups to discuss the content of the Options List and the delivery of the intervention. In phase three we will automate the BFM intervention using an existing web-based computer touch-screen platform. In phase four we will conduct individual patient debriefing interviews with 30 patients to evaluate the understandability of the BFM survey. In phase five we will evaluate the test/re-test reliability of the survey in a new sample of 30 patients. BFM intervention implementation will include a stratified randomization of patients to the BFM intervention or usual care. BFM intervention evaluation will include testing the feasibility, acceptability, and outcomes associated with the intervention versus usual care in a single trial with 200 patients (100 intervention and 100 usual care).
- Conditions
- Schizophrenia
- Being tested
- Antipsychotic medication adherence intervention
- Keywords
- patient non-adherence, intervention studies
- Medical subject headings
- Schizophrenia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotic medication adherence interventionBehavioural
The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention. |
| Antipsychotic adherence intervention | Experimental | Antipsychotic Medication Adherence Intervention which included the Barriers, Facilitators, and Motivators Checklist summary and Adherence tips provided in hard copy to patient and electronic copy to mental health provider. Receives: Behavioral: Antipsychotic medication adherence intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipsychotic Medication Adherence
The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey M. Pyne, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144027
- Sponsor's protocol ID
- IIR 03-257
- Acronym
- AMAIS
- Status last verified
- Jul 2014
- First submitted
- 1 Sep 2005
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pyne JM, Fischer EP, Gilmore L, McSweeney JC, Stewart KE, Mittal D, Bost JE, Valenstein M. Development of a Patient-Centered Antipsychotic Medication Adherence Intervention. Health Educ Behav. 2014 Jun;41(3):315-24. doi: 10.1177/1090198113515241. Epub 2013 Dec 25.
PubMed 24369177
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Medication Adherence Intervention for Schizophrenia
- ClinicalTrials.gov ID
- NCT00144027
- Acronym / sponsor ID
- AMAIS / IIR 03-257
- Conditions
- Schizophrenia
- Keywords
- patient non-adherence, intervention studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 23 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. One reason for this is the substantial resource investment necessary to implement and sustain available interventions. In response to these problems, we developed a patient-centered adherence intervention based on patient-identified barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention includes a BFM survey (checklist and preference weighting exercise to determine the patient's most important BFM) and a brief list of adherence enhancing suggestions (Options List) tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention. The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to: 1. Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction, provider intervention input, and patient intervention input. We hypothesize that our use of end-user input will result in at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2. Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity. We hypothesize that the intervention will result in a) greater medication adherence and b) lower schizophrenia symptom severity than usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life. We hypothesize that the intervention will result in greater health-related quality of life than usual care.
Detailed description
BFM intervention refinement will be accomplished in five phases. Phase one will include reducing the number of items in the BFM checklist by administering the expanded checklist to at least 50 patients with schizophrenia and using the standard psychometric item-reduction strategies to create a shorter checklist. In phase two we will conduct mental health provider focus groups to discuss the content of the Options List and the delivery of the intervention. In phase three we will automate the BFM intervention using an existing web-based computer touch-screen platform. In phase four we will conduct individual patient debriefing interviews with 30 patients to evaluate the understandability of the BFM survey. In phase five we will evaluate the test/re-test reliability of the survey in a new sample of 30 patients. BFM intervention implementation will include a stratified randomization of patients to the BFM intervention or usual care. BFM intervention evaluation will include testing the feasibility, acceptability, and outcomes associated with the intervention versus usual care in a single trial with 200 patients (100 intervention and 100 usual care).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention. |
| Antipsychotic adherence intervention | Experimental | Behavioral: Antipsychotic medication adherence interventionAntipsychotic Medication Adherence Intervention which included the Barriers, Facilitators, and Motivators Checklist summary and Adherence tips provided in hard copy to patient and electronic copy to mental health provider. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical chart diagnosis of schizophrenia or schizoaffective disorder;
- currently prescribed outpatient antipsychotic medication (oral or depot);
- patient must have adequate capacity to provide informed consent, understand the nature of the study, and sign an informed consent document.
Key exclusion criteria (1 listed)
- significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation-Memory-Concentration (BOMC) Test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipsychotic medication adherence interventionThe medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. | Behavioural | Antipsychotic adherence intervention |
Primary outcome
Antipsychotic Medication Adherence
Time frame: 6-months
The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24369177Pyne JM, Fischer EP, Gilmore L, McSweeney JC, Stewart KE, Mittal D, Bost JE, Valenstein M. Development of a Patient-Centered Antipsychotic Medication Adherence Intervention. Health Educ Behav. 2014 Jun;41(3):315-24. doi: 10.1177/1090198113515241. Epub 2013 Dec 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M. Pyne, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipsychotic medication adherence intervention in people with Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antipsychotic Medication Adherence (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.